KDMF (Korea Drug Master File) Approved Products & Companies

Hana Pharmaceutical Co., Ltd.

  • Product:

    felodipine

  • Initial Registration:

    2006-01-31

  • Registration Number:

    20060131-69-B-213-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hana Pharmaceutical Co., Ltd.

  • Last Modified:

    2008-02-25

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Hana Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    133, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

Hanall Biopharma Co., Ltd.

  • Product:

    Fudostein

  • Initial Registration:

    2004-06-22

  • Registration Number:

    35-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Hanall Biopharma Co., Ltd.

  • Last Modified:

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Dojin Lyaku-Kako Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    263-1, Higashidai Ottozowa, Okum-machi, Futa-gun Fukishima-prefecture, Japan

Hanareum Farm Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2011-12-15

  • Registration Number:

    20070504-4-B-240-14(10)

  • MFDS Classification:

  • Applicant:

    Hanareum Farm Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Jiangxi Fengxin Industrial Park, Fengxin 330700, Jiangxi Province, China

Handok Co., Ltd.

  • Product:

    Roxithromycin

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-9-A-4-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Handok Co., Ltd.

  • Last Modified:

    2025-10-29

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    EUROAPI France

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    4 La Paterie, Vertolaye, 63480, France

Handok Consumption Co., Ltd.

  • Product:

    Pegsetacoplan

  • Initial Registration:

    2024-04-29

  • Registration Number:

    Su318-6-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Handok Consumption Co., Ltd.

  • Last Modified:

    2025-10-29

  • Country:

    Swiss

  • Status:

    Active

  • Manufacturer:

    Bachem AG

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Hauptstrasse 144, 4416 Bubendorf, Switzerland

Handok Teva Co., Ltd.

  • Product:

    Formoterol fumarate hydrate

  • Initial Registration:

    2015-06-02

  • Registration Number:

    20150226-187-I-450-07(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Handok Teva Co., Ltd.

  • Last Modified:

  • Country:

  • Status:

    Active

  • Manufacturer:

    Sicor Societa' Italiana Corticosteroidi srl@[micronization process] Micro-Macinazione SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Via Terrazzano, 77-20017 Rho (MI). Italy@Via Cantonale 4, 6995 Madonna del Piano, Switzerland

Hanjin Pharmaceutical

  • Product:

    Simvastatin

  • Initial Registration:

    2016-11-14

  • Registration Number:

    20120217-29-B-327-26(9)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hanjin Pharmaceutical

  • Last Modified:

    2020-05-26

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Jiangbei Pharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Dongdai village Zhang an Street, Jiaojiang, Taizhlu, Zhejiang, China

Hanlim Pharmaceutical Co., Ltd.

  • Product:

    Topiso Farm

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-64-C-191-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hanlim Pharmaceutical Co., Ltd.

  • Last Modified:

    2022-05-26

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Sanyo Chemical Laboratories Co., Ltd. Toyama Factory

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    1-5-1, Yasuuchi, Yatsuo-Machi, Toyama-Shi, Toyama, 939-2366, Japan

Hanmi Fine Chemical Co., Ltd.

  • Product:

    Acecclofenac

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-31-C-102-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hanmi Fine Chemical Co., Ltd.

  • Last Modified:

    2019-07-15

  • Country:

  • Status:

    Active

  • Manufacturer:

    [Manufacturer of Substance under Act II] ITChem Co., Ltd. @ Hanmi Fine Chemical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    [Manufacturer of Substance No. 2] 231, Yangcheongsongdae-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungbuk (Factory 1) @ 57, Gyeongje-ro, Siheung-si, Gyeonggi-do

Hanmi Pharmaceutical Co., Ltd.

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2009-03-31

  • Registration Number:

    20090331-96-E-81-24

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Hanmi Pharmaceutical Co., Ltd.

  • Last Modified:

    2022-11-30

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Hanmi Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    114 Chupalsandan-ro, Pyeongseong-eup, Pyeongtaek-si, Gyeonggi-do

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